Clinical Trial: Alemtuzumab and CHOP in T-cell Lymphoma
Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Randomized Phase III Study to Evaluate the Efficacy of Chemoimmunotherapy With the Monoclonal Antibody Campath-1H (Alemtuzumab) Given in Combination With 2-weekly CHOP Versus 2-weekly CHOP Alone and
Brief Summary: The purpose of this study is to determine efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with chemotherapy in the treatment of T-cell lymphoma.
Detailed Summary:
First International phase III T-cell lymphoma study Indication:Newly diagnosed non-cutaneous peripheral T-cell lymphoma Study objectives:Determination of the efficacy and safety of the monoclonal antibody MabCampath® (alemtuzumab) combined with two-weekly CHOP supported by G-CSF Primary Endpoint: Event-Free-Survival (EFS) Study Design: International open-label, multicentre, randomized Phase III Study
Study Medication: Patients are randomized to six cycles of two-weekly CHOP plus G-CSF with or without alemtuzumab given subcutaneously 30 mg day 1 in combination with chemotherapy cycles 1-4. Patients in CR, CRu and PR after the 6 cycles of CHOP14 combined or not with alemtuzumab will receive a consolidation with high-dose chemotherapy followed by autologous stem cell transplantation.
Patient Population: Patients > 18 yrs with newly diagnosed non-cutaneous, non-leukemic PTCL, except alk-protein positive and negative anaplastic large cell lymphoma Planned Sample Size: 308 young patients (18-60 yrs) registered and randomized Total Number of Centers: This study will be proposed to main European and Australian Study Groups.
Sponsor: Aarhus University Hospital
Current Primary Outcome: Event-free Survival [ Time Frame: The EFS is defined by the time between day of randomization until an event occurs, up to 96 months ]
Original Primary Outcome: Event-free Survival [ Time Frame: The EFS is defined by the time between day of randomization until an event occurs ]
Current Secondary Outcome:
- Overall survival [ Time Frame: From the time of randomisation to date of last follow-up or death, up to 96 months ]
- Overall response rate [ Time Frame: from date of randomization to date of primary response assessment, up to 96 months ]
- Overall response rate related to the CD52 expression [ Time Frame: From date of randomization to date of primary response assessment, up to 96 months ]
- Tumor control or time-to-progression [ Time Frame: time of randomization to last follow-up or time of disease progression, up to 96 months ]
- Safety measured as number of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: from randomization to closure of study, up to 96 months ]
- Feasibility of successful stem cell harvest i.e. >/=2E6 CD34 positive cells [ Time Frame: from start of priming regimen to time of assessment of stem cell harvest, up to 96 months ]
Original Secondary Outcome:
- Overall survival [ Time Frame: From the time of randomisation to date of last follow-up or death ]
- Progression-free survival [ Time Frame: From date of randomization to date of last follow-up or disease progression ]
- Overall response rate [ Time Frame: from date of randomization to date of primary response assessment ]
- Overall response rate related to the CD52 expression [ Time Frame: From date of randomization to date of primary response assessment ]
- Tumor control or time-to-progression [ Time Frame: time of randomization to last follow-up or time of disease progression ]
- Safety [ Time Frame: from randomization to closure of study ]
- Feasibility of successful stem cell harvest. [ Time Frame: from start of priming regimen to time of assessment of stem cell harvest ]
Information By: University of Aarhus
Dates:
Date Received: February 14, 2008
Date Started: June 2008
Date Completion: December 2016
Last Updated: January 8, 2015
Last Verified: November 2012